A Multicenter Phase 2 Study of CI-1040 In Patients With Advanced Nonsmall-Cell Lung Cancer, Breast Cancer, Colon Cancer Or Pancreatic Cancer
OBJECTIVES:
- Determine the antitumor activity of CI-1040 in patients with non-small cell lung,
breast, colon, or pancreatic cancer.
- Determine the safety profile of this drug in these patients.
- Assess quality of life (overall and for each tumor type) of patients treated with this
drug.
- Determine the relationship between study drug concentration and antitumor response in
these patients and target suppression and safety of this drug.
- Correlate target suppression (pERK) with antitumor effects of this drug in these
patients.
- Correlate the mRNA expression profile of the tumors with antitumor effects of this drug
in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to tumor type
(non-small cell lung vs breast vs colon vs pancreas).
Patients receive oral CI-1040 twice daily on days 1-21. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 28 days during the first 6 months of
study therapy.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 52-172 patients (13-43 per stratum) will be accrued for this
study.
Interventional
Primary Purpose: Treatment
John J. Rinehart, MD
Study Chair
University of Alabama at Birmingham
United States: Food and Drug Administration
CDR0000069279
NCT00033384
February 2002
November 2003
Name | Location |
---|---|
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |